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Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Argus Health
Cantor Fitzgerald
Daiichi Sankyo
Fuji
Harvard Business School
Teva
Dow
US Army

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201675

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NDA 201675 describes ESTRADIOL, which is a drug marketed by Mylan Technologies, Ortho Mcneil Pharm, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Mylan, Usl Pharma, Amneal Pharms, Teva Pharms Usa, Barr, Breckenridge Pharm, Mylan Labs Ltd, Watson Labs, Luitpold, Sandoz Inc, and Watson Labs Inc, and is included in twenty-two NDAs. It is available from thirty-five suppliers. Additional details are available on the ESTRADIOL profile page.

The generic ingredient in ESTRADIOL is estradiol valerate. There are seventy-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.
Summary for 201675
Tradename:ESTRADIOL
Applicant:Mylan Technologies
Ingredient:estradiol
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 201675
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 201675
Suppliers and Packaging for NDA: 201675
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 201675 ANDA Mylan Pharmaceuticals Inc. 0378-4640 0378-4640-26 8 POUCH in 1 CARTON (0378-4640-26) > 1 PATCH in 1 POUCH (0378-4640-16) > 3.5 d in 1 PATCH
ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 201675 ANDA Mylan Pharmaceuticals Inc. 0378-4641 0378-4641-26 8 POUCH in 1 CARTON (0378-4641-26) > 1 PATCH in 1 POUCH (0378-4641-16) > 3.5 d in 1 PATCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.025MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.0375MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength0.05MG/24HR
Approval Date:Dec 19, 2014TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Julphar
Farmers Insurance
UBS
McKesson
Teva
Boehringer Ingelheim
Fuji

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